Cognitive-Behavioral Therapy for Avoidant/Restrictive Food Intake Disorder: A Treatment Development and Pilot Study

Avoidant/Restrictive Food Intake Disorder (ARFID) Clinical Trial

— CBT-AR Pilot  

Official title:

Cognitive-Behavioral Therapy for Avoidant/Restrictive Eating Disorder: A Treatment Development and Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02963220
• Other study ID #: 2016P002108
• Status: Completed
• Phase: N/A
• Start date: October 2016
• Est. completion date: October 2020

Study information

• Verified date: February 2021
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary aim of this study is to pilot cognitive behavioral therapy (CBT-AR)for avoidant/restrictive food intake disorder (ARFID) in one study for children and adolescents (ages 10-17 years) and one study for adults (ages 18-65 years).

Description:

This study is designed to pilot the CBT-AR treatment in youth with ARFID to determine treatment acceptability and efficacy.This includes evaluating the efficacy and acceptability of CBT-AR in reducing primary ARFID symptoms from pre- to post-treatment, and to assess whether improvement in individual symptoms is related to the timing of relevant interventions. The investigators hypothesize that from pre-treatment to post-treatment, subjects with ARFID will decrease severity of self-reported ARFID symptoms, decrease self-reported anxiety and depression, and improve psychosocial functioning. The investigators further hypothesize that overall, subjects with ARFID will have reduced phobic avoidance, sensory sensitivity, and/or low appetite in comparison to their pre-treatment symptoms.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: October 2020
• Est. primary completion date: October 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 65 Years

Eligibility

Inclusion Criteria:

• Males and females; ages 10-17 years AND 18-65 years with avoidant/restrictive eating disorder or avoidant/restrictive eating patterns, characterized by either (i) Eating Disorder Assessment-5 (EDA-5) (ii) Kiddie Schedule for Affective Disorders and Schizophrenia for School Age Children-Present and Lifetime Version (KSADS-PL)

Exclusion Criteria:

• Use of systemic hormones, pregnancy or breastfeeding within eight weeks
• History of psychosis by KSADS-PL
• Substance or Alcohol Use Disorder active within the past month by KSADS-PL
• Active suicidal ideation
• Gastrointestinal tract surgery (including gastrectomy, gastric bypass surgery, and small or large bowel resection)
• Any feeding or eating disorder other than ARFID determined by EDA-5
• Any clinically significant disordered eating as evidenced by EDE-Q global > 4.0 or self-induced vomiting, laxatives, diuretics, purposeful fasting, or compensatory exercise in past 28 days
• Medical history of intellectual disability (IQ< 70)
• Has previously received more than 4 hours of CBT for ARFID in the past
• Is currently receiving another form of psychosocial treatment for ARFID (e.g., occupational therapy, speech therapy, another form of psychotherapy) and is unable to discontinue that treatment for the duration of this study.

Related Conditions & MeSH terms

• Avoidant/Restrictive Food Intake Disorder (ARFID)
• Disease

Intervention

Behavioral:
• CBT-AR
20-30 sessions of cognitive behavioral therapy for avoidant/restrictive food intake disorder (CBT-AR), held once per week in an outpatient setting

Locations

Country	Name	City	State
United States	Eating Disorders Clinical and Research Program (Massachusetts General Hospital)	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Massachusetts General Hospital	American Psychological Foundation, The Hilda & Preston Davis Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pica, ARFID, Rumination Disorder Interview (PARDI) severity score	A semi-structured interview to assess pica, ARFID, and/or rumination disorder diagnosis, severity, and symptoms	Change from pre-treatment to after 20 weeks of CBT-AR (or 40 weeks, if the patient is underweight [BMI < 18.5 kg/m^2])
Secondary	BMI (kg/m^2)	If the patient is underweight, BMI will be used as an outcome measure	Change from pre-treatment to after 20 weeks of CBT-AR (or 40 weeks, if the patient is underweight [BMI < 18.5 kg/m^2])
Secondary	Food Neophobia Scale	Patient will complete the FNS prior to treatment and again after 20 (or 40 week) to assess change in reluctance to new foods	Change from pre-treatment to after 20 weeks of CBT-AR (or 40 weeks, if the patient is underweight [BMI < 18.5 kg/m^2])
Secondary	Parent PARDI	A semi-structured interview to assess pica, ARFID, and/or rumination disorder diagnosis, severity, and symptoms (based on parent report)	Change from pre-treatment to after 20 weeks of CBT-AR (or 40 weeks, if the patient is underweight [BMI < 18.5 kg/m^2])
Secondary	Child Depression Inventory 2 (CDI 2) score	Patient will complete the CDI 2 prior to treatment and again after 20 (or 40 weeks) to assess change in severity of depression	Change from pre-treatment to after 20 weeks of CBT-AR (or 40 weeks, if the patient is underweight [BMI < 18.5 kg/m^2])
Secondary	State-Trait Anxiety Inventory (STAI) score	Patient will complete the STAI prior to treatment and again after 20 (or 40 weeks) to assess change in severity of anxiety	Change from pre-treatment to after 20 weeks of CBT-AR (or 40 weeks, if the patient is underweight [BMI < 18.5 kg/m^2])
Secondary	Clinical Impairment Assessment (CIA) score	Patient will complete the CIA prior to treatment and again after 20 (or 40 weeks) to assess change in severity of clinical impairment	Change from pre-treatment to after 20 weeks of CBT-AR (or 40 weeks, if the patient is underweight [BMI < 18.5 kg/m^2])
Secondary	Hormone data	Patient will complete a test meal and we will collect blood at T0, T30, T60, and T120 prior to treatment and again after 20 (or 40) weeks of CBT-AR, in order to assess the change in hormone levels.	Change from pre-treatment to after 20 weeks of CBT-AR (or 40 weeks, if the patient is underweight [BMI < 18.5 kg/m^2])
Secondary	Functional magnetic resonance imaging (fMRI)	Patient will complete fMRI scan prior to treatment and again after 20 (or 40) weeks of CBT-AR, in order to assess the change in fMRI paradigms.	Change from pre-treatment to after 20 weeks of CBT-AR (or 40 weeks, if the patient is underweight [BMI < 18.5 kg/m^2])